Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)

Brief description of study

IBIS is a prospective, observational study, which aims to assess the cost of CDI per day,
hospitalization and year including description of incremental costs in hospitalized patients,
and recurrent episodes, in German hospitals. Exposure to CDI drugs will not be influenced and
remains at the discretion of the treating physician.

In addition to treatment, Health-related quality of life (HRQL) will be analyzed using
standardized questionnaires.

Detailed Study Description

Documentation of patient is performed by using the web-based survey platform
www.ClinicalSurveys.net which was set up by researchers of the University Hospital of
Cologne. This survey platform enables an optimal performance in epidemiological,
observational, and interventional trials and is characterized by layered access security and
frequent data backup. It has been used for numerous registry and cohort studies with approval
of competent authorities and ethics boards.

The following two differences of data documentation are observed:

Retrospective data documentation:

Data of patients that are too sick to provide informed consent, (up to 30% of all
patients enrolled) will be obtained retrospectively, at least 90 days after diagnosis
and will be documented in an anonymized fashion. For these patients, documentation of
HRQL will not be feasible.

2. Prospective data documentation:

Data of patients with an informed consent.

The following data items are retrospectively or prospectively documented into our database,
depending on if a informed consent exists or not:

Demography: age (yrs), gender (m/f), comorbidities (as categories)

Charlson Comorbidity Index (CCI)

Karnofsky Score (0-100%)

APACHE Score for patients in ICU

Number of hospitalizations in the past 12 months prior to the CDI index episode